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A Safety and Efficacy Study of Tralokinumab in Adults With Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

NCT01402986•MedImmune LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

Detailed Description

Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in improved control of asthma. This study will determine whether the addition of tralokinumab to standard asthma medications results in a reduced rate of asthma exacerbations in subjects with severe asthma.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18-75 years
•Body mass index (BMI) between 16-40 kilogram per square meter (kg/m\^2) at Visit 1
•Uncontrolled severe asthma
•A chest x-ray with no abnormality
•Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1
•Non-sterilized males or sterilized males who are less than or equal to (=\<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception

Exclusion Criteria

•Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
•Pregnant or breastfeeding women
•Any other respiratory disease
•Previously taken tralokinumab (the study drug)
•Current smoker or a history of smoking which would be more than 1 pack per day for 10 years
•Known immune deficiency
•History of cancer
•Hepatitis B, C or Human Immuno-deficiency Virus (HIV)
•Any disease which may cause complications whilst taking the study drug.

Locations (89)

Research Site

Rancho Mirage, California, United States

Research Site

Centennial, Colorado, United States

Research Site

New Haven, Connecticut, United States

Research Site

Cocoa, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Winter Park, Florida, United States

Research Site

Albany, Georgia, United States

Research Site

Fargo, North Dakota, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Upland, Pennsylvania, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

June 1, 2013

Completion Date

February 1, 2014

Last Updated

April 4, 2017

Enrollment

689

ACTUAL participants

Conditions

Asthma

Interventions

Placebo Q2W

OTHER

Tralokinumab 300 mg, Q2W

BIOLOGICAL

Placebo, Q2/4W

OTHER

Tralokinumab 300 mg, Q2/4W

BIOLOGICAL

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGPHASE2

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma